Fatty Acid Antiarrhythmia Trial (FAAT)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00004559
First received: February 9, 2000
Last updated: November 10, 2005
Last verified: November 2005
  Purpose

To determine if the dietary N-3 class of polyunsaturated fatty acids (PUFAs) provided in the diet largely from marine fish oils would prevent fatal ventricular tachycardia (VT) or ventricular fibrillation (VF).


Condition Intervention Phase
Arrhythmia
Heart Diseases
Tachycardia, Ventricular
Ventricular Fibrillation
Behavioral: dietary polyunsaturated fatty acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: March 1999
Estimated Study Completion Date: February 2002
Detailed Description:

BACKGROUND:

Sudden death is a common manifestation of ischemic heart disease and therefore of great public health concern. Unfortunately several promising antiarrhythmic drugs proved not to be effective in preventing sudden deaths. This project would test whether a relatively inexpensive and presumably innocuous therapy, fish oil supplements, can prevent life-threatening arrhythmias. There is ample basic evidence that n-3 fatty acids contained in fish oil supplements may suppress arrhythmias, and a clinical trial seems warranted.

DESIGN NARRATIVE:

Prospective, randomized, placebo-controlled, double-blind. Patients were randomized to 4 grams per day of a PUFA fish oil supplement versus an olive oil placebo. The number of therapeutic discharges were recorded from the ICDs and then confirmed from the recorded electrocardiogram strips with the kinds of arrhythmias which had induced the ICD response. The primary end point, time to first ICD event for ventricular tachycardia or fibrillation (VT or VF) confirmed by stored electrograms or death from any cause, was analyzed by intention to treat.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00004559     History of Changes
Other Study ID Numbers: 127
Study First Received: February 9, 2000
Last Updated: November 10, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014